IPHARMA Pharmacovigilance

IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.

Services

International standards and Regulatory Authorities make demands on drug developers and holders of marketing authorization to ensure safety.

IPHARMA provides the following pharmacovigilance services:

1. Pharmacovigilance system management

Pharmacovigilance system master file development and adaptation
Providing pharmacovigilance platform to drug developers and holders of marketing authorization

2. Pre-marketing pharmacovigilance

Safety plan development
Receipt, review, sending and tracking of SAE reports
Receipt, review, sending and tracking of SUSAR and SAR reports
Receipt, review, sending and tracking of DSUR and PSUR reports
Organizing the work of Data safety monitoring board with the involvement of independent experts and arrangement of the meetings
Providing the reports to Russian and EAEU Regulatory Authorities

3. Post-marketing pharmacovigilance

Preparation of a Patient information leaflet based on the IB data and/or clinical study reports
Risk management plan (RMP) preparation
Post-marketing studies conduct
Receipt, review, database entry and tracking of adverse reactions, individual intolerance and other circumstances that may cause risks for health and life of a patient when using a drug
Analysis of databases and literature sources, search and validation of signals
Internal reports preparation
Periodic safety update reports (PSUR) reparation and its submission to the regulatory authorities of the EAEU and Russia

4. Pharmacovigilance Quality Assurance